48 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERTEBRON SCP CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Trilogy
FDA UDI
Respironics, Inc.·00606959022720·Trilogy 202 Ventilator, German Version
NAV 3.5mm DRILL
FDA UDI
Osteocentric Technologies, Inc.·00810097803527·NAV 3.5mm DRILL
n/a
FDA UDI
Ortho Development Corporation·00822409073726·10/12 Collar Reamer LRG
23GA Curved Illuminating Probe, SMA905
FDA UDI
Peregrine Surgical, Llc·00632307001680·23GA Curved Illuminating Probe, SMA905
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481115172·F-Tx Attachment System, Narrow CrossFit (NC) Co...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110351·LOCATOR Abutment R-Tx, Narrow CrossFit Internal...
SURE LOCK,A34,10 PK,RED LEVER,CURBELL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828183321·SURE LOCK,A34,10 PK,RED LEVER,CURBELL
SURELOCK, CURBELL, RED, 14 PK
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828185912·SURELOCK, CURBELL, RED LEVER, 14 PACK
TORNIER TOTAL ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
FDA 510(k)
FDA Class 2
·Orthopedic
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·EXABLATE 2000 SYSTEM
CHLORAPREP ONE STEP HI LITE ORANGE
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXG·June 23, 2021
Atlas
FDA UDI
Eyoto, Inc.·05070000542829·Automated AC powered Ophthalmic Lens Analyser f...
MOSS VRS
FDA Adverse Event
Injury
·BIEDERMANN MOTECH GMBH & CO. KG·Product code NKB·February 12, 2025
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·EXABLATE 2000 SYSTEM
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·InSightec ExAblate System
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·EXABLATE
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·EXABLATE SYSTEM
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·EXABLATE 2000/2100 1.5 AND 3T